VNS Therapy Receives CE Mark for Expanded MRI Labeling

1.8.2017 06:30 | Business Wire

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LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a
market-leading medical technology company, today announced its latest VNS
Therapy® Systems (“VNS Therapy”) received CE Mark for
expanded MRI labeling. VNS Therapy is now the only implantable device
indicated for epilepsy therapy that allows patients to have high-quality
1.5T and 3T MRI scans without the need for special equipment.

“The CE Mark comes one month after we received U.S.
FDA approval for similar expanded MRI labeling,” said Damien
McDonald, LivaNova’s Chief Executive Officer. “Earning CE Mark and FDA
approval to expand our MRI labeling removes a barrier to care for
patients with drug-resistant epilepsy.”

The labeling change applies to the latest VNS Therapy technology, which
includes AspireHC® and AspireSR® devices. Now,
patients who have or desire to have VNS Therapy can more easily receive
routine MRI scans.

“In addition to offering patients more seizure-free moments, we can now
better support comprehensive epilepsy treatment throughout a patient’s
lifetime,” adds Jason Richey, LivaNova’s President of North America &
General Manager of the Neuromodulation franchise.

To date, more than 100,000 patients worldwide use VNS Therapy—a
minimally invasive treatment designed to prevent seizures before they
start and stop them if they do. More than one in three people with
epilepsy has drug-resistant seizures, meaning seizures persist in spite
of treatment with antiepileptic medications.1 To learn more,
visit www.VNSTherapy.com
or www.SeizureControl.com.

INTENDED USE/INDICATION – EPILEPSY – EU

The VNS Therapy System is indicated for use as an adjunctive therapy in
reducing the frequency of seizures in patients whose epileptic disorder
is dominated by partial seizures (with or without secondary
generalization) or generalized seizures that are refractory to seizure
medications.

AspireSR™ (Seizure Response) features the Automatic Stimulation Mode
which is intended for patients who experience cardiac rhythm increases
that are associated with seizures.

Common side effects include hoarseness or changes in voice tone,
prickling feeling in the skin, shortness of breath, sore throat and
coughing. Visit www.VNSTherapy.com/important-safety-information
to view safety and full prescribing information.

LivaNova PLC is a global medical technology company built on nearly five
decades of experience and a relentless commitment to improve the lives
of patients around the world. LivaNova’s advanced technologies and
breakthrough treatments provide meaningful solutions for the benefit of
patients, healthcare professionals and healthcare systems. Headquartered
in London and with a presence in more than 100 countries worldwide, the
company employs more than 4,500 employees. LivaNova operates as three
business franchises: Cardiac Surgery, Neuromodulation and Cardiac Rhythm
Management, with operating headquarters in Mirandola (Italy), Houston
(U.S.A.) and Clamart (France), respectively.